A Clinical Evaluation of Metal Ion Release From Metal-on-Metal Cementless Total Hip Arthroplasty
Information source: Biomet, Inc.
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoarthritis; Avascular Necrosis; Traumatic Arthritis; Rheumatoid Arthritis
Intervention: metal on metal hip arthroplasty (Procedure)
Phase: N/A
Status: Recruiting
Sponsored by: Biomet, Inc. Official(s) and/or principal investigator(s):
Evert J Smith, FRCS, Principal Investigator, Affiliation: Avon Orthopaedic Centre
Overall contact:
Evert J Smith, FRCS, Phone: +44(0)1179595207
Summary
A clinical Evaluation to determine metal ion release from 4th generation metal-on-metal hip
articulating surfaces in cementless total hip arthroplasty.
Clinical Details
Official title: A Clinical Evaluation of Metal Ion Release From Metal-on-Metal Cementless Total Hip Arthroplasty
Study design: Treatment, Open Label, Single Group Assignment, Safety Study
Primary outcome: concentration of Cobalt, Chromium and Molybdenum ions in urine
Secondary outcome: harris Hip Score, oxford hip, WOMAC and SF-12
Detailed description:
This evaluation is being conducted to investigate the extent of metal ion release and its
incorporation into the surrounding tissue resulting from metal on metal articulating surfaces
in cementless total hip arthroplasty.
The amount of metallic ions released post operatively will be assessed by the concentration
of Cobalt, Chromium and Molybdenum present in urine and analysed by I. C.P. M.S. (Inductive
Coupled Plasma Mass Spectroscopy). The amounts of metallic ions released will be related to
the hip function and range of motion measured pre-operatively and post-operatively. Secondary
performance of the metal-on-metal articulation will be determined by radiographic evaluation
and incidence of complications / revision rates.
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Subjects selected for this Evaluation will be grouped by initial diagnosis into one of
the following diagnostic groups:
- Non-inflammatory degenerative joint disease including osteoarthritis, avascular
necrosis and traumatic arthritis.
- Rheumatoid arthritis.
- Selection of subjects for this Evaluation should include the following
considerations:
- Patients under 70 years of age.
- Willing to return for follow-up evaluations.
- No bias to sex.
Exclusion Criteria:
Locations and Contacts
Evert J Smith, FRCS, Phone: +44(0)1179595207
Avon Orthopaedic Centre, Bristol, United Kingdom; Recruiting
Evert J Smith, FRCS, Phone: +44(0)1179595207
Additional Information
Starting date: March 2006
Ending date: March 2020
Last updated: September 22, 2008
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